Effect of a Soy Dietary Supplement on Menopausal Symptoms and Hormones in Women at High Risk of Breast Cancer.
Abstract
Women at high risk for breast cancer who are experiencing menopausal symptoms of hot flashes are being recruited for our study in Boston and surrounding areas. Breast Health Clinics and Women's Clinics are being used to inform women about the study. Radio advertising has also been used to locate our study population which has been highly successful. We have currently recruited 80 out of the 100 being sought. Women with greater than or equal 5 symptoms per day are randomized, using a double-blind, cross-over study design, to receive either a placebo bar or soy supplement bar for 3 months with one month of wash-out between protocols. Two blood samples are taken at baseline and during the last week of each of the two 3 month study periods. Serum levels of estrone, estradiol, free-estradiol, estrone-sulfate, androstenedione, luteinizing and follicle stimulating hormone are measured. Subjects keep a daily symptoms diary for the entire seven month study. A sub-set of women (N=10) will have serum genistein and diadzien analyzed to determine if their levels match their Asian counterparts. A matched group of control women with less than or equal 2 hot flashes/day are currently being recruited. Fourteen have been recruited. This study proposes to determine: (1) if a dietary soy supplement bar (containing 45 mg of phytoestrogens) relieves menopausal hot flash symptoms compared to a placebo bar, (2) if a dietary soy supplement bar affects hormone levels, and (3) the relationship between menopausal symptoms and hormone levels.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1997
- Accession Number
- ADA336566
Entities
People
- Margo N. Woods
Organizations
- Tufts University